Guot
Conditions
Interventions
Trial Group:Daily consumption of Taiji Mountain Spring Water 1860 ml (6 cans)
Control Group 1:Daily consumption of purified water 1860 ml (6 cans)
Control Group 2:Daily consumption of mineral water 1860 ml (6 cans)
Sponsors
The Affiliated Hospital of North Sichuan Medical College
Eligibility
Sex/Gender
All
Age
16 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 16–65 years, meeting the 2015 ACR/EULAR clinical classification criteria for gout; 2. Serum uric acid level >=480 µmol/L (8 mg/dL); 3. No acute gouty arthritis attacks in the 2 weeks prior to treatment and during the first 2 weeks of treatment; 4. Suitable for febuxostat or benzbromarone treatment, with no allergies or contraindications to the drugs or their components; 5. Obtained informed consent voluntarily signed by the participant, family member, guardian, or legal representative.
Exclusion criteria
Exclusion criteria: 1. Patients with active peptic ulcers, thyroid dysfunction, malignant tumors, active tuberculosis, and urinary calculi. 2. Heart failure, unstable angina pectoris, patients with a history of myocardial infarction or other serious heart diseases within the past 12 months. 3. Patients with hematological diseases, malignant tumors, kidney tumors or those undergoing tumor radiotherapy, etc., who have secondary gout or hyperuricemia. 4. Patients with mild or above renal insufficiency (eGFR 160 mmHg or diastolic blood pressure > 100 mmHg). 7. Patients with brain diseases, abnormal judgment ability, or mental disorders that cannot cooperate. 8. Patients who are heavy drinkers or have a history of taking prohibited drugs. 9. Pregnant women, lactating women, or those preparing for pregnancy (including male participants). 10. Any other reasons, as determined by the researcher, that make them unsuitable to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Achieving the target blood uric acid concentration: for men, it should be less than 420 µmol/L; for women, it should be less than 360 µmol/L; for subjects in the stable period, the blood uric acid should be less than 300 µmol/L.;The control rate of serum uric acid concentration;Blood uric acid concentration reached the target time; | — |
Secondary
| Measure | Time frame |
|---|---|
| The percentage of patients with SUA<360umol/L at least once;;The percentage of patients with serum uric acid <300umolL at the last visit;;Number of acute gout episodes and percentage of patients:;Changes from baseline in blood glucose, blood lipid (triglyceride, total cholesterol, high density lipoprotein, low density lipoprotein), serum creatinine, blood urea nitrogen, alanine aminotransferase, aspartate aminotransferase at the last visit;;Change from baseline in eGFR at final visit:;The change in blood pressure from baseline to the last visit;;Changes from baseline in urinary ultrasound at the last visit;Adverse events such as gastrointestinal reactions and serious adverse events;Vital signs, laboratory tests and electrocardiogram; | — |
Countries
China
Contacts
Public ContactQing Yufeng
The Affiliated Hospital of North Sichuan Medical College
Outcome results
None listed